PMI Urges FDA To Renew IQOS MRTP Status, Citing Strong Evidence Of Reduced Harm And Switching

(RTTNews) - Philip Morris International Inc. (PM) announced that it recently presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), a panel of independent scientific researchers that offers nonbinding recommendations to the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP). The full-day meeting held on October 7 was part of the FDA's standard review process for PMI's request to continue marketing its IQOS heated tobacco products in the U.S. as modified risk tobacco products (MRTPs). This review is a necessary step while the FDA evaluates pending applications for IQOS ILUMA—a newer version of the IQOS models already authorized—to help transition more legal-age adults away from combustible cigarettes.

Stacey Kennedy, CEO of PMI U.S., emphasized that the evidence presented further supports the FDA's original conclusions that led to the authorization of the IQOS system as a modified risk tobacco product. She urged the FDA to maintain a timely scientific review process for smoke-free products, including IQOS ILUMA, which has been under FDA review for nearly two years. Globally, IQOS ILUMA has demonstrated even higher rates of complete switching among legal-age adults from traditional cigarettes, making it a better alternative for those who would otherwise continue smoking.

According to the company, the IQOS system operates by heating tobacco rather than burning it, which significantly reduces the production of harmful chemicals and users' exposure to them. It still delivers the taste and ritual of smoking, which helps maximize complete switching from cigarettes.

As of June 30, 2025, PMI estimates that approximately 34 million legal-age consumers worldwide use IQOS, many of whom have either quit smoking or significantly reduced their cigarette consumption. The MRTP renewal application includes two device versions—IQOS 2.4 and IQOS 3.0 holders and chargers—and three tobacco consumable variants: Amber HEETS, Green Menthol HEETS, and Blue Menthol HEETS.

The FDA originally granted MRTP status to the IQOS system in 2020, allowing PMI to communicate specific claims to legal-age consumers. These include that the IQOS system heats tobacco without burning it, significantly reduces the production of harmful and potentially harmful chemicals, and that scientific studies show complete switching from conventional cigarettes to IQOS reduces exposure to these chemicals.

During the meeting, PMI highlighted its responsible marketing practices and presented additional research showing high levels of complete switching among adult smokers, while maintaining low usage rates among unintended populations.